ADA Linagliptin in Long Term Care

NCT02061969 | Completed Phase 4 Results DMC

• 2 other identifiers: IRB00071545IRB00071946
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 4

Brief Summary

This is a study to determine whether glycemic control, as measured by change in HbA1c and frequency of hypoglycemia, is different between treatment with linagliptin (Tradjenta®) and basal insulin in long term care residents(LTC) with Type 2 diabetes(T2D). Patients with poorly controlled diabetes (HbA1c \>7.5%) will be randomized to a 6-month intervention with linagliptin or glargine insulin (± metformin for both treatments). Our hypothesis is that treatment with linagliptin, a once daily DPP4-inhibitor, will result in similar improvement in glucose control but in a lower rate of hypoglycemia than insulin treatment in LTC residents with T2D. We will also determine differences in clinical outcome, resource utilization, and hospitalization costs between LTC residents with T2D treated with linagliptin and basal and correction insulin. We will compare differences in complications (infectious and non-infectious, neurological and cardiovascular events), emergency room visits and hospitalizations between groups during the 6 months of intervention.

Conditions

Diabetes

Keywords

nursing home facility; long-term care facility; older patients; elderly patients; hyperglycemia; type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• Mean Fasting Blood Glucose Level

  The primary endpoint of the study is differences between treatment groups in mean fasting blood glucose level in LTC residents with poorly controlled diabetes.

  6 months

Secondary Outcomes (11)

• HbA1c

  6 months

• Number of Hypoglycemic Events < 70mg/dl

  over 6 months

• Number of Hypoglycemic Events < 40mg/dl

  over 6 months

• Total Daily Dose of Insulin

  over 6 months

• Changes in Cognitive Function

  over 6 months

Study Arms (2)

Insulin glargine

ACTIVE COMPARATOR

Insulin glargine starting at 0.1 unit/kg/day added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.

Drug: insulin glargine

linagliptin

EXPERIMENTAL

Oral linagliptin 5mg once daily added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.

Drug: linagliptin

Interventions

linagliptin DRUG

5mg linagliptin tablets

Also known as: Tradjenta

linagliptin

insulin glargine DRUG

Also known as: Lantus

Insulin glargine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females with known history of type 2 diabetes, treated with diet, OADs as monotherapy or in combination therapy (excluding DPP4 inhibitors), or sliding scale insulin.
• Subjects with HbA1c \> 7.5% and/or any blood glucose greater than or equal to 180 mg/dL

You may not qualify if:

• Subjects with a history of type 1 diabetes or with a history of diabetic ketoacidosis
• Treatment with insulin or GLP1 analogs during the past 3 months prior to admission.
• Recurrent severe hypoglycemia or hypoglycemic unawareness.
• Subjects with history of gastrointestinal obstruction or gastroparesis.
• Patients with acute or chronic pancreatitis or pancreatic cancer.
• Patients with clinically significant hepatic disease (cirrhosis, jaundice, end-stage liver disease, portal hypertension) and elevated ALT and AST \> 3 times upper limit of normal, or significantly impaired renal function (GFR \< 45 ml/min).
• Treatment with corticosteroids, parenteral nutrition and immunosuppressive treatment.
• Mental condition rendering the subject unable to understand the nature and scope of the study.

Sponsors & Collaborators

• Emory University: lead
• American Diabetes Association: collaborator

Study Sites (4)

Crestvew Nursing Home

Atlanta, Georgia, 30315, United States

Location

Budd Terrace Nursing Home

Atlanta, Georgia, 30322, United States

Location

Wesley Woods Nursing Home

Atlanta, Georgia, 30322, United States

Location

VA Nursing Home

Decatur, Georgia, 30033, United States

Location

Related Publications (1)

• Umpierrez GE, Cardona S, Chachkhiani D, Fayfman M, Saiyed S, Wang H, Vellanki P, Haw JS, Olson DE, Pasquel FJ, Johnson TM 2nd. A Randomized Controlled Study Comparing a DPP4 Inhibitor (Linagliptin) and Basal Insulin (Glargine) in Patients With Type 2 Diabetes in Long-term Care and Skilled Nursing Facilities: Linagliptin-LTC Trial. J Am Med Dir Assoc. 2018 May;19(5):399-404.e3. doi: 10.1016/j.jamda.2017.11.002. Epub 2017 Dec 27.

  PMID: 29289540 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Hyperglycemia; Diabetes Mellitus, Type 2

Interventions

Linagliptin; Insulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Saumeth Cardona MD
• Organization: Emory University

scardon@emory.edu

404-616-4827

Study Officials

• Guillermo Umpierrez, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 11, 2014
• First Posted: February 13, 2014
• Study Start: April 25, 2014
• Primary Completion: April 10, 2017
• Study Completion: April 10, 2017
• Last Updated: August 22, 2018
• Results First Posted: August 22, 2018

Record last verified: 2018-07

Locations

US (4)